RINVOQ™ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis

-       Positive top-line study results show that both doses of RINVOQ™ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response in adult patients with active psoriatic arthritis who had an inadequate response to other bDMARDs at week 12 versus placebo¹

-         At week 12, 57/64 percent of patients receiving 15/30 mg of RINVOQ achieved ACR20, respectively, compared to 24 percent in the placebo group¹

-         At week 16, 52/57 percent of patients on 15/30 mg of RINVOQ achieved a PASI 75 response, respectively, compared to 16 percent on placebo¹

-         At week 24, 25/29 percent of 15/30 mg RINVOQ-treated patients achieved minimal disease activity, respectively, compared to 3 percent in the placebo group¹

-         The safety profile of RINVOQ was consistent with that of previous studies across indications, with no new safety risks detected^1,2

NORTH CHICAGO, Ill., October 31, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line data from the SELECT-PsA 2 Phase 3 study. In this study, both doses of RINVOQ™ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs).¹ In addition, patients on both doses of RINVOQ achieved significantly greater responses compared to placebo for all ranked secondary endpoints.¹ SELECT-PsA 2 is the first study evaluating the efficacy and safety of RINVOQ in adult patients with active psoriatic arthritis.¹ RINVOQ, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated diseases^1,3-10

“Too many people living with psoriatic arthritis still fail to achieve their treatment goals, underscoring a clear medical need for additional therapeutic options,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We are pleased with these data, which show the potential of RINVOQ to improve outcomes for people with psoriatic arthritis across a variety of symptoms. Data from this Phase 3 study will support regulatory submissions for RINVOQ in psoriatic arthritis.”

Results show that at week 12, 57/64 percent of patients receiving 15/30 mg of RINVOQ achieved ACR20, respectively, compared to 24 percent in the placebo group (p<0.0001).¹ Additionally, ACR50 was achieved by 32/38 percent of patients receiving 15/30 mg of RINVOQ, respectively, compared to 5 percent on placebo at week 12 (p<0.0001).¹ 9/17 percent of patients achieved ACR70 in the 15/30 mg RINVOQ groups, respectively, compared to 0.5 percent in the placebo group at week 12 (p<0.0001).¹ Patients receiving RINVOQ also had greater improvements in physical function at week 12, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). RINVOQ showed improvement in skin symptoms at week 16, with 52/57 percent of patients receiving 15/30 mg of RINVOQ achieving a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75), respectively, compared to 16 percent on placebo (p<0.0001).¹ 25/29 percent of 15/30 mg RINVOQ-treated patients achieved minimal disease activity (MDA) at week 24 (p<0.0001), respectively, compared to 3 percent in the placebo group.¹

SELECT-PsA 2 Efficacy Results^1,†

	RINVOQ 15 mg (n=211)	RINVOQ 30 mg (n=218)	Placebo (n=212)
ACR20a at week 12	57%	64%	24%
ACR50a at week 12	32%	38%	5%
ACR70a at week 12	9%	17%	0.5%
HAQ-DIb at week 12	-0.30	-0.41	-0.10
PASI 75c at week 16	52%	57%	16%
MDAd at week 24	25%	29%	3%

^†Primary endpoint was ACR20 at week 12. All reported endpoints achieved p-values of <0.0001 versus placebo for both doses. Not all ranked secondary endpoints shown.

^aACR20/50/70 is defined as at least a 20 percent/50 percent/70 percent reduction from baseline in the number of both tender and swollen joint counts and equivalent improvement in three or more of the five remaining American College of Rheumatology core set measures: patient assessments of pain, global disease activity, physical function, physician global assessment of disease activity and acute phase reactant.

^b HAQ-DI is defined as change in baseline in the Health Assessment Questionnaire Disability Index, which is a is a patient-reported questionnaire including categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.

^c PASI 75 is defined as a 75 percent improvement in the Psoriasis Area Severity Index. It was assessed in patients with ≥3 percent body surface area (BSA) psoriasis at baseline.

^d MDA is defined as the fulfillment of 5 of 7 outcome measures: TJC ≤1; SJC ≤1; PASI ≤1 or BSA-Ps ≤3 percent; Patient's Assessment of Pain NRS ≤1.5; PtGA-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and LEI (Leeds Enthesitis Index) ≤1.

In this study, the safety profile of RINVOQ was consistent with that observed in previously reported studies in patients with rheumatoid arthritis, with no new safety risks detected.^1,2 Through week 24, serious infections occurred in 0.5/2.8 percent of patients in the 15/30 mg RINVOQ groups, respectively, compared to 0.5 percent in the placebo group.¹ There was one pulmonary embolism reported in the 15 mg RINVOQ group and none in the 30 mg and placebo groups. There was one non-fatal adjudicated major adverse cardiovascular event (MACE) in the 15 mg RINVOQ group (acute myocardial infarction) and no MACE in the 30 mg and placebo groups. One death was reported in a patient receiving placebo (motor vehicle accident).

Psoriatic arthritis is a heterogeneous systemic inflammatory disease with hallmark manifestations in joints and skin, affecting more than 50 million people worldwide.^11,12 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue and stiffness in the joints.¹¹

Full results from the SELECT-PsA 2 study will be presented at a future medical meeting and published in a peer-reviewed publication.

About SELECT-PsA 2^1,13

SELECT-PsA 2 is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one bDMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.

The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment. Secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. The trial is ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of the two once-daily doses (15 mg and 30 mg) of RINVOQ in patients who have completed the placebo-controlled period. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).

About RINVOQ (upadacitinib)

Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.^1-10 Earlier this year, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis. RINVOQ also received a positive opinion from the European Union’s Committee for Medicinal Products for Human Use and is currently awaiting final approval by the European Commission. Phase 3 trials of RINVOQ in psoriatic arthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing and it is also being investigated to treat ankylosing spondylitis.^1,6-10

Important Safety Information about RINVOQ™ (upadacitinib)

RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?

RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

·   Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).

·   Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.

·   Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.

·   Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

What should I tell my HCP BEFORE starting RINVOQ?

Tell your HCP if you:

·   Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of an infection such as:

̶    Fever, sweating, or chills ̶    Shortness of breath ̶    Warm, red, or painful skin or sores on your body

̶    Muscle aches ̶    Feeling tired ̶    Blood in phlegm ̶    Diarrhea or stomach pain

̶    Cough ̶    Weight loss ̶    Burning when urinating or urinating more often than normal

·   Have TB or have been in close contact with someone with TB.

·   Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.

·   Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.

·   Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.

·   Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.

·   Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.

·   Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

·   Medicines for fungal or bacterial infections

·   Rifampicin or phenytoin

·   Medicines that affect your immune system

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?

Tell your HCP right away if you:

·   Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.

·   Have any signs or symptoms of blood clots during treatment with RINVOQ, including:

̶    Swelling ̶    Pain or tenderness in the leg

̶    Sudden unexplained chest pain ̶    Shortness of breath

·   Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

 

What are the common side effects of RINVOQ?

These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. 

This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.